May cause a shift in potassium from extracellular to intracellular space, possibly leading to hypokalemia; caution when coadministered with potassium-lowing drugs or conditions that may decrease potassium

Frequent glucose monitoring and insulin dose reduction may be required with renal or hepatic impairment

Thiazolidinediones are peroxisome proliferator-activated receptor (PPAR)-gamma agonists and can cause dose-related fluid retention, particularly when used in combination with insulin; fluid retention may lead to or exacerbate heart failure, monitor for signs and symptoms of heart failure and treat accordingly and consider discontinuing thiazolidinediones

Never share a pen between patients even if the needle is changed

Patients using vials must never share needles or syringes with another person

Changes in insulin, insulin strength, manufacturer, type, or method of administration may affect glycemic control and predispose to hypoglycemia or hyperglycemia; changes should be made cautiously and only under close medical supervision and frequency of blood glucose monitoring should be increased; for patients with type 2 diabetes, dosage adjustments in concomitant oral anti-diabetic treatment may be needed

Accidental mix-ups between insulin products reported; to avoid medication errors between APIDRA and other insulins, instruct patients to always check insulin label before each injection

If hypersensitivity reactions occur, discontinue therapy; treat per standard of care and monitor until symptoms and signs resolve; drug is contraindicated in patients who have had a hypersensitivity reaction to it or any of its excipients

Do not mix SC injection with insulin preparations other than NPH insulin

SC insulin infusion

Do not dilute or mix with any other insulin

Insulin in the reservoir must be changed at least every 48 hr

Do not expose to temperatures >98.6 F (37 C)

Malfunction of the insulin pump or infusion set, or handling errors or insulin degradation can rapidly lead to hyperglycemia, ketosis and diabetic ketoacidosis; prompt identification and correction of cause of hyperglycemia or ketosis necessary; patients using continuous subcutaneous insulin infusion pump therapy must be trained to administer insulin by injection and have alternate insulin therapy available in case of pump failure

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Pregnancy & Lactation

Pregnancy

Available pharmacovigilance data have not established an association with insulin glulisine use during pregnancy and major birth defects, miscarriage or adverse maternal or fetal outcomes; there are risks to mother and fetus associated with poorly controlled diabetes in pregnancy

Animal reproduction studies have been conducted with insulin glulisine in rats and rabbits using regular human insulin as a comparator; insulin glulisine was given to female rats throughout pregnancy at subcutaneous doses up to 10 units/kg/day (2 times the average human dose, based on body surface area comparison) and to rabbits during organogenesis at subcutaneous doses up to 1.5 units/kg/day (0.5 times the average human dose, based on body surface area comparison); effects did not differ from those observed with subcutaneous regular human insulin

Lactation

Available data from published literature suggest that human insulin products are transferred into human milk; there are no adverse reactions reported in breastfed infants in literature; there are no data on effects of exogenous human insulin products, on milk production; developmental and health benefits of breastfeeding should be considered along with mother’s clinical need for therapy and any potential adverse effects on breastfed infant or from underlying maternal condition

Pregnancy Categories

A:Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

B:May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

C:Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

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Compare formulary status to other drugs in the same class.

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The above information is provided for general
informational and educational purposes only. Individual plans may vary
and formulary information changes. Contact the applicable plan
provider for the most current information.

View explanations for tiers and
restrictions

Tier

Description

1

This drug is available at the lowest co-pay. Most
commonly, these are generic drugs.

2

This drug is available at a middle level co-pay. Most
commonly, these are "preferred" (on formulary) brand drugs.

3

This drug is available at a higher level co-pay. Most
commonly, these are "non-preferred" brand drugs.

4

This drug is available at a higher level co-pay. Most
commonly, these are "non-preferred" brand drugs or specialty
prescription products.

5

This drug is available at a higher level co-pay. Most
commonly, these are "non-preferred" brand drugs or specialty
prescription products.

6

This drug is available at a higher level co-pay. Most
commonly, these are "non-preferred" brand drugs or specialty
prescription products.

NC

NOT COVERED – Drugs that are not
covered by the plan.

Code

Definition

PA

Prior Authorization Drugs that
require prior authorization. This restriction requires that
specific clinical criteria be met prior to the approval of the
prescription.

QL

Quantity Limits Drugs that
have quantity limits associated with each prescription. This
restriction typically limits the quantity of the drug that will
be covered.

ST

Step Therapy Drugs that have
step therapy associated with each prescription. This restriction
typically requires that certain criteria be met prior to
approval for the prescription.

OR

Other Restrictions Drugs that
have restrictions other than prior authorization, quantity
limits, and step therapy associated with each prescription.